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The Role of OCTA in Patients Affected by Beta Thalassemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04582110
Recruitment Status : Completed
First Posted : October 9, 2020
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Gilda Cennamo, Federico II University

Study Description
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Brief Summary:
To investigate, using optical coherence tomography angiography (OCTA), the retinal and choriocapillaris vascular features in patients affected by Beta Thalassemia. Moreover we analyzed the structural retinal parameters (ganglion cell complex and retinal nerve fiber layer), using optical coherence tomography (OCT) in these patients

Condition or disease Intervention/treatment
Thalassemia Diagnostic Test: Optical coherence tomography angiography

Detailed Description:

Beta Thalassemia is one of the most common genetic hemoglobinopathy characterized by a defective β globulin chain synthesis leading to hemolysis and ineffective erythropoiesis.

The study investigated the changes in retinal and choriocapillaris vascular features using optical coherence tomography angiography, a novel and noninvasive diagnostic technique that allows a detailed analysis of retinal and choriocapillaris blood flow.

Study Design
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Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Retinal and Choriocapillaris Vascular Features in Patients With Beta Thalassemia by Means of Optical Coherence Tomography Angiography
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : February 25, 2020
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with Beta Thalassemia
Patients with previous diagnosis of Beta Thalassemia
 Diagnostic Test: Optical coherence tomography angiography
Each subject underwent Optical coherence tomography angiography (a non-invasive, fast, diagnostic imaging technique)
Control Group
Healthy fellow eyes without actual and previous ocular trauma
 Diagnostic Test: Optical coherence tomography angiography
Each subject underwent Optical coherence tomography angiography (a non-invasive, fast, diagnostic imaging technique)


Outcome Measures
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Primary Outcome Measures :
  1. The measurements of retinal and choriocapillaris features in patients with Beta Thalassemia, using optical coherence tomography angiography. [ Time Frame: Four months ]
    The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillaris vessel density


Secondary Outcome Measures :
  1. The measurements of retinal structural parameters in patients with Beta Thalassemia, using optical coherence tomography. [ Time Frame: Four months ]
    The parameters analyzed by optical coherence tomography were: ganglion cell complex and retinal nerve fiber layer


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The participans were older than 35 years with diagnosis of Beta Thalassemia. They did not present other ophthalmological diseases.
Criteria

Inclusion Criteria:

  • age older than 35 years
  • diagnosis of Beta Thalassemia
  • absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
  • absence of significant lens opacities, low-quality OCT and OCT-A images.

Exclusion Criteria:

  • age older than 50 years
  • absence of diagnosis of Beta Thalassemia
  • presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
  • presence of significant lens opacities, low-quality OCT and OCT-A images.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582110


Locations
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Italy
University of Naples "Federico II"
Naples, Italy, 80100
Sponsors and Collaborators
Federico II University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Gilda Cennamo, Principal Investigator, Federico II University
ClinicalTrials.gov Identifier: NCT04582110    
Other Study ID Numbers: 1002/19
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn